interim report april –june 2020€¦ · interim report april –june 2020 for the extended fiscal...

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Interim report April – June 2020 For the extended fiscal year July 2019 ‐ December 2020 August 11 th , 2020 at 3:00 p.m. CET. Dial‐in: SE: +46 8 505 583 50, US: +1 833 526 83 82. Anna Ljung, CEO

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Page 1: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

Interim report April – June 2020For the extended fiscal year July 2019 ‐ December 2020

August 11th, 2020 at 3:00 p.m. CET. Dial‐in: SE: +46 8 505 583 50, US: +1 833 526 83 82. Anna Ljung, CEO

Page 2: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

DisclaimerThe purpose of this presentation (the "Presentation") is to provide an overview of Moberg Pharma AB (publ) (the "Company"). For the purposes of this notice, "Presentation" means this document, its contents or any part of it, any oral presentation, any question or answer session and any written or oral material discussed or distributed during the Presentation meeting. 

This Presentation is not a prospectus or similar offer document. This Presentation does not purport to contain comprehensive or complete information about the Company and is qualified in its entirety by the business, financial and other information the Company is required to publish in accordance with the rules, regulations and practices applicable to companies listed on Nasdaq Stockholm (the "Exchange Information"). Any decision to invest in any securities of the Company should only be made on the basis of a thorough examination of the Exchange Information and an independent investigation of the Company itself and not on the basis of this Presentation. Neither this Presentation nor any of the Exchange Information has been independently verified by any other person unless expressly stated therein. No representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy or completeness of the information or opinions contained in this Presentation.

Except where otherwise indicated in this Presentation, the information provided herein is based on matters as they exist at the date of preparation of this Presentation and not as of any future date. All information presented or contained and any opinions expressed in this Presentation are subject to change without notice. None of the Company or any of its directors, officers, employees, agents, affiliates or advisers is under any obligation to update, complete, revise or keep current the information contained in this Presentation to which it relates or to provide the recipient of with access to any additional information that may arise in connection with it. 

This Presentation contains "forward‐looking" statements. These forward‐looking statements can be identified by the fact that they do not relate only to historical or current facts. In particular, forward‐looking statements include all statements that express forecasts, expectations, plans, outlook and projections with respect to future matters, including trends in results of operations, margins, growth rates, overall market trends, the impact of interest or exchange rates, the availability or cost of financing, anticipated cost savings or synergies, the completion of strategic transactions and restructuring programmes, anticipated tax rates, expected cash payments, and general economic conditions. By their nature, forward‐looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and they are subject to change at any time. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward‐looking statements, including risks associated with the inherent uncertainty of pharmaceutical research and product development, manufacturing and commercialization, the impact of competitive products, patents, legal challenges, government regulation and approval, the Company’s ability to secure new products for commercialization and/or development and other risks and uncertainties detailed from time to time in the Company’s interim or annual reports, prospectuses or press releases and other factors that are outside the Company's control. Any forward‐looking statements made by or on behalf of the Company speak only as of the date they are made. The Company does not undertake to update forward‐looking statements to reflect any changes in the Company's expectations with regard thereto or any changes in events, conditions or circumstances on which any such statement is based. 

2

Page 3: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

Moberg Pharma 2.0

Pipeline progress

Financial performance

Focus forward

Page 4: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

4

Moberg Pharma in brief

Moberg Pharma develops and commercializes medical products that relieve pain and skin conditions, especially nail fungus 

• 2 products in phase 3:

– MOB‐015 Topical terbinafine against nail fungus

– BUPI Bupivacaine lozenge against OM

• Potential market leaders with $250‐500m (MOB‐015) and $100‐200m (BUPI) estimated sales potential

• Phase 3 studies recently completed

– Primary endpoint met both in North America (n = 365) and Europe (n = 452)

• License agreements signed with TDV $120 million plus supply fees and royalties

• Opportunity to commercialize and drive growth through co‐promotion in the U.S. and strong partners in other territories

• Patent protection until 2032

Page 5: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

Moberg Pharma 2.0

Pipeline progress

Financial performance

Focus forward

Page 6: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

6

Significant events in 2020

The primary endpoint was met in the European phase 3 study 

• MOB‐015 Phase 3 program for EU met the primary endpoint, showing non‐inferiority vs ciclopirox 

– Consistent data with North American study

– Low Complete Cure but early onset and very strong Mycological Cure of 84%

• No significant impact of COVID‐19 to date

• Financing agreement of up to SEK 216 million

• Dr Cindy Wong was appointed Chief Medical Officer and a member of the Executive Management 

• Expert evaluation confirmed the validity of the results of the phase 3 studies in North America and Europe;

– 70‐84 % of the patients were fungus free, which is world leading for a topical treatment, but increased hydration causes temporary whitening, which makes the assessment of clinical cure more challenging 

– Shorter treatment period should solve this problem

Page 7: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

• The European Phase III study for MOB‐015 was conducted at Germany, the U.K. and Poland. 452 patients were randomized 2:1 to MOB‐015 and 8 percent ciclopirox. Patients were treated once daily for 48 weeks, with last follow‐up at week 52

• Key results from the study include:– Primary end point met (non‐inferiority), but at a lower complete cure (1.8% vs 1.6%) than 

expected– Mycological cure significantly higher and more rapid then expected, reaching 84% at week 52– 46% of patients mycologically cured already at 12 weeks– No safety issues

7

Results in Europe is consistent with the results of the phase 3 study in North America

Page 8: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

8

Expecting higher complete cure rates based on the superior mycological cure rates

Source: U.S. prescribing information for each drug; for P‐3058, https://www.clinicaltrialsregister.eu/ctr‐search/trial/2015‐000561‐31/results 

MOB‐015 NA

Ciclopirox 8%

Efinaconazole 1

Efinaconazole 2

Tavaborole 1 Tavaborole 2

Oral terbinafine

Itraconazole

Luliconazole

Terbinafine P‐3058 

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

0% 5% 10% 15% 20% 25% 30% 35% 40%

Mycolog

ical cure

Complete cure

MOB‐015 EU

Page 9: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

Based on the expert discussions, and analysis of all available data including the phase 3 data, earlier trials, and literature data, the company experts and KOLs concluded:  

• A shorter dosing regimen followed by a maintenance period is likely to result in increased complete cure rate, based on:– Early onset and high mycological cure demonstrated– Very high terbinafine levels in nail/nail bed– 3 months treatment with oral terbinafine is effective– Reduction of the hydrating effect after the initial treatment phase and thus reducing the impact 

on the clinical cure assessment at week 52

• The evaluation concluded that a preferred regimen would be once‐daily dosing for not more than three months, followed by maintenance treatment once weekly until week 48

9

Shorter treatment ‐ a solution to the problem 

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• Unusual situation ‐ requires further dialogue with regulatory agencies and partners. Outcomes of clinical studies normally are more uniform 

• Primary endpoint achieved in both the NA study and the EU study – the two studies can serve as a basis for product registration in Europe 

• For market approval in the U.S., FDA normally requires two studies showing superiority for the primary endpoint– an additional study likely needed for U.S. registration

We are now discussing next steps for MOB‐015 with our partners and regulatory agencies

10

Next steps

Page 11: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

Moberg Pharma 2.0

Pipeline progress

Financial performance

Focus forward

Page 12: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

Cash Flows  (SEK thousand) Apr‐Jun Apr‐ Jun2020 2019

Operating profit before financial items ‐6,312 ‐4,060Financial items, received and paid, and taxes paid ‐171 ‐32,862Depreciation/amortization and other adjustments 629 ‐4,396Employee share‐based adjustments to equity 320 528Change in working capital 3,301 ‐23,084OPERATING CASH FLOW ‐2,233 ‐63,874

CASH FLOW FROM INVESTING ACTIVITIES ‐18,268 ‐13,451

Financing activitiesIssue/Repayment of loans 5,093 ‐600,000Repayment of leases ‐618 ‐514Issue of new shares less transaction costs 684 30CASH FLOW FROM FINANCING ACTIVITIES 5,159 ‐600,484

Change in cash and cash equivalents ‐15,342 ‐677,809Cash and cash equivalents at beginning of period 51,616 1,596,943Cash and cash equivalents at the end of period 36,274 919,134

Financial performance – rationalised cost base vs previous period

12Due to the rounding component, totals may not tally. 

P&L  (SEK thousand) Apr‐Jun Apr‐JunContinuing operations 2020 2019Net revenue ‐ ‐Selling expenses 5 ‐222Business development and administrative expenses ‐5,502 ‐8,511Research and development costs ‐762 ‐3,602Other operating income/operating expenses ‐53 3,164Operating profit (EBIT) ‐6,312 ‐9,171

Interest income/interest expenses and similar items ‐203 ‐619Tax on profit for the period 1,282 2,189PROFIT FOR THE PERIOD FROM CONTINUING OPERATIONS ‐5,233 ‐7,601Profit after tax for the period from discontinued operations  ‐ 2,512PROFIT FOR THE PERIOD ‐5,233 ‐5,089

Balance Sheet (SEK thousand) 2020.06.30 2019.06.30AssetsIntangible assets 306,911 255,654Property, plant and equipment 21 80Right‐of‐use assets 8,025 10,493Deferred tax asset 6,213 11,617Total non‐current assets 321,170 277,844

Trade receivables and other receivables 6,747 12,994Cash and cash equivalents 36,274 919,134Total current assets 43,020 932,128

TOTAL ASSETS 364,191 1,209,972

Equity (attributable to parent company’s shareholders) 328,401 1,121,030Non‐current liabilities 5,890 32,038Current liabilities 29,900 56,904TOTAL EQUITY AND LIABILITIES 364,191 1,209,972

Page 13: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

Moberg Pharma 2.0

Pipeline progress

Financial performance

Focus forward

Page 14: Interim report April –June 2020€¦ · Interim report April –June 2020 For the extended fiscal year July 2019 ‐December 2020 August 11th, 2020 at 3:00 p.m. CET. Dial‐in:SE:

14

Focus on delivering pipeline value

Aiming to create the next market leader in onychomycosis Continuing to create value for the shareholders of Moberg Pharma with a business strategy centered around MOB‐015 

• MOB‐015 Topline‐results:– Delivered December 2019 for North America, primary endpoint met– Delivered June 2020 for North Europe, primary endpoint met

• SEK 216 million financing agreement secured

• License agreements signed with TDV $120 million plus supply fees and royalties.

– Bayer AG in Europe– Taisho in Japan– Cipher in Canada– DongKoo in Korea

• Opportunity to commercialize and drive growth through co‐promotion in the U.S. and strong partners in other territories

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Moberg Pharma AB (Publ)Gustavslundsvägen 42, 5 tr.

167 51 Brommamobergpharma.se